Completed

NCT Number: NCT01299532

Macrolane VRF30 for Enhancement of Shape and Fullness of Female Breast

This is an open, multi-center, non comparative study to evaluate the safety and efficacy of Macrolane VRF30 in the female breast. 71 subjects have received initial treatment with a maximum of 120 ml of Macrolane VRF30 per breast. 22 patients have received a re-injection (max 120 ml/breast) of Macrolane nine months after initial treatment. Patients are followed for 24 months after last treatment.

Completed

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Key information

Conditions

Breast Enhancement

Age range

25 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

L'Institute du Sein, Paris, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients between 25 and 60 years with small breasts seeking enhancement of the shape and fullness of the breast

Exclusion criteria

Unreasonable expectations as regards the increase in breast volume
Any medical conditions that may interfere in any way.

Treatment and study plan

Macrolane VRF30

Device

Device: Macrolane VRF30 (stabilized hyaluronic acid of non-animal origin) Treatment: Initial injection of a maximum of 120 ml/breast. Re-injection of a maximum of 120 ml/breast in a subgroup of subjects.

Primary outcomes

Perceived improvement of shape and fullness of the female breast compared to baseline as judged by the subject using GEIS.

Time frame: 6 months

Secondary outcomes

To evaluate the safety as documented by physical examination, mammography, ultrasonography and by adverse events reported.

Time frame: 24 months
To evaluate adverse experiences occurring during the first 2 weeks post treatment as recorded in the diary.

Time frame: 2 weeks
to study the implant duration and localization as documented by MRI.

Time frame: 24 months
to evaluate esthetic improvement of shape and fullness as judged by an independent evaluator, by the investigator and by the subject using GEIS.

Time frame: 24 months
to evaluate the subjects satisfaction with her breast and general appearance using a subject questionnaire.

Time frame: 24 months
to evaluate pain experience during injection under local anesthesia.

Time frame: during injection
To evaluate any difficulties with the interpretation of the mammography image(s)or ultrasonography due to the presence of the implant 24 months after the initial treatment

Time frame: 24 months
Re-treatment phase: To evaluate the safety documented by physical examination and by adverse events reported up to 24 months after re-treatment and by mammography and ultrasonography examinations 15 and 39 months after re-treatment.

Time frame: 39 months
Re-treatment phase: To evaluate any difficulties with the interpretation of the mammography image(s) or ultrasonography due to the presence of the implant 24 and 48 months after the initial treatment (15 and 39 months after the re-treatment).

Time frame: 48 months
Re-treatment phase: To evaluate adverse experiences occurring during the first 2 weeks post re-treatment as recorded in the diary.

Time frame: 2 weeks
Re-treatment phase: To study the implant duration and localization as documented by MRI up to 24 months after re-treatment.

Time frame: 24 months
Re-treatment phase: To evaluate esthetic improvement of shape and fullness as judged by an independent evaluator, by the investigator and by the subject using GEIS up to 24 months after re-treatment.

Time frame: 24 months
Re-treatment phase: To evaluate, up to 24 months after re-treatment, the subjects satisfaction with her breast and general appearance using a subject questionnaire.

Time frame: 24 months
Re-treatment phase: To evaluate pain experience during re-injection under local anaesthesia.

Time frame: During re-injection
Re-treatment phase: To evaluate if there are differences in esthetic improvement, subject satisfaction and implant duration, after re-treatment compared to after initial treatment. The visits up to 9 months will be compared.

Time frame: 9 months
Re-treatment phase: To compare esthetic improvement, subject satisfaction and implant duration at 24 months after last treatment between subjects that have received only one treatment and subjects that have received re-treatment.

Time frame: 24 months
Re-treatment phase: To compare esthetic improvement, subject satisfaction and implant duration at 12 and 24 months after initial treatment between subjects that have received only one treatment and subjects that have received re-treatment.

Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

An Open, Multi-center Study Evaluating Efficacy and Safety of Macrolane VRF30 for Enhancement of the Shape and Fullness of the Female Breast

Acronym: COBRA

Important dates

Study start: 2008
Primary completion: 2010
Study completion: 2013
First posted: Feb 18, 2011
Registry last updated: Sep 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Key information

Conditions

Age range

Sex eligibility

Study type

Phase

Primary location

Who can participate

Treatment and study plan

Macrolane VRF30

Primary outcomes

Perceived improvement of shape and fullness of the female breast compared to baseline as judged by the subject using GEIS.

Secondary outcomes

To evaluate the safety as documented by physical examination, mammography, ultrasonography and by adverse events reported.

To evaluate adverse experiences occurring during the first 2 weeks post treatment as recorded in the diary.

to study the implant duration and localization as documented by MRI.

to evaluate esthetic improvement of shape and fullness as judged by an independent evaluator, by the investigator and by the subject using GEIS.

to evaluate the subjects satisfaction with her breast and general appearance using a subject questionnaire.

to evaluate pain experience during injection under local anesthesia.

To evaluate any difficulties with the interpretation of the mammography image(s)or ultrasonography due to the presence of the implant 24 months after the initial treatment

Re-treatment phase: To evaluate the safety documented by physical examination and by adverse events reported up to 24 months after re-treatment and by mammography and ultrasonography examinations 15 and 39 months after re-treatment.

Re-treatment phase: To evaluate any difficulties with the interpretation of the mammography image(s) or ultrasonography due to the presence of the implant 24 and 48 months after the initial treatment (15 and 39 months after the re-treatment).

Re-treatment phase: To evaluate adverse experiences occurring during the first 2 weeks post re-treatment as recorded in the diary.

Re-treatment phase: To study the implant duration and localization as documented by MRI up to 24 months after re-treatment.

Re-treatment phase: To evaluate esthetic improvement of shape and fullness as judged by an independent evaluator, by the investigator and by the subject using GEIS up to 24 months after re-treatment.

Re-treatment phase: To evaluate, up to 24 months after re-treatment, the subjects satisfaction with her breast and general appearance using a subject questionnaire.

Re-treatment phase: To evaluate pain experience during re-injection under local anaesthesia.

Re-treatment phase: To evaluate if there are differences in esthetic improvement, subject satisfaction and implant duration, after re-treatment compared to after initial treatment. The visits up to 9 months will be compared.

Re-treatment phase: To compare esthetic improvement, subject satisfaction and implant duration at 24 months after last treatment between subjects that have received only one treatment and subjects that have received re-treatment.

Re-treatment phase: To compare esthetic improvement, subject satisfaction and implant duration at 12 and 24 months after initial treatment between subjects that have received only one treatment and subjects that have received re-treatment.

Sponsors and collaborators

Lead sponsor

Registry information

Official study title

Important dates

Related clinical trials

Macrolane for Enhancement of the Shape and Fullness of the Female Breast

An Extension of CTN 31GB0607 to Evaluate Long Term Safety of NASHA Treatment in the Breast